Efficacy of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy for Helicobacter pylori eradication

doi:10.1046/j.1365-2036.2002.01130.x

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Wiley InterScience

Alimentary Pharmacology & Therapeutics

Volume 16 Issue 1, Pages 145 - 151

Published Online: 11 Jan 2002

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Efficacy of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy for Helicobacter pylori eradication

I. J. Choi ¹ , H. C. Jung ¹ , K. W. Choi ² , J. H. Kim ³ , D. S. Ahn ⁴ , U. S. Yang ⁵ , J. S. Rew ⁶ , S. I. Lee ⁷ , J. C. Rhee ² , I. S. Chung ⁸ , J. M. Chung ⁹ & W.-S. Hong ¹⁰

¹ Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Clinical Research Institute, Seoul National University Hospital, Seoul, South Korea, ² Department of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, South Korea, ³ Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea, ⁴ Department of Internal Medicine, Chonbuk National University College of Medicine, Chonju, South Korea, ⁵ Department of Internal Medicine, Pusan National University College of Medicine, Pusan, South Korea, ⁶ Department of Internal Medicine, Chonnam National University College of Medicine, Kwangju, South Korea, ⁷ Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea, ⁸ Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea, ⁹ Department of Internal Medicine, Kyungpook National University College of Medicine, Taegu, South Korea, ¹⁰ Department of Internal Medicine, University of Ulsan College of Medicine, Seoul, South Korea

Correspondence to: Dr H. C. Jung, Department of Internal Medicine, Seoul National University College of Medicine, 28 Yungon-dong, Chongno-gu, Seoul 110-744, South Korea. E-mail: hyunchae@plaza.snu.ac.kr

ABSTRACT

Background:

Proton pump inhibitor-based triple therapies are recommended as the first-line treatment for Helicobacter pylori eradication.

Aim:

To evaluate the efficacies of low-dose clarithromycin triple therapy and tinidazole-containing triple therapy in a metronidazole resistance prevalent area and to compare the efficacies with standard triple therapy.

Methods:

In a randomized, multicentre, prospective study, a total of 352 patients with duodenal ulcer or non-ulcer dyspepsia were randomly divided into three groups according to the administered regimen: OAC250 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 250 mg), OAC500 group (omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg) and OTC group (omeprazole, 20 mg, tinidazole, 500 mg, and clarithromycin, 500 mg). The three groups received each regimen twice daily for 7 days. Upper gastrointestinal endoscopy was performed before and 4 weeks after treatment. H. pylori status was determined by rapid urease test and ¹³C urea breath test.

Results:

The eradication rates in the OAC250, OAC500 and OTC groups were 76.2%, 65.7% and 64.8% (95% confidence interval: 67.9–84.4%, 56.7–74.8% and 55.7–73.9%), respectively, by intention-to-treat analysis (P=0.149) and 92.8%, 87.2% and 84.1% (95% confidence interval: 84.4–97.3%, 77.9–93.8% and 73.9–91.2%), respectively, by per protocol analysis (P=0.088). All regimens were well tolerated and compliance was excellent.